Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ASA · 2 trials · 1 indication
The bioavailability of two test products was compared with the reference products after determining the plasma PK parameters: Cmax (maximum measured plasma concentration), Tmax (time of Cmax), AUC0-t (area under the plasma concentration versus time curve from time zero to the last measurable concentration), AUC0-infinity (AUC from zero to infinity), t1/2 (time required for the plasma drug concentration to decrease by one half), Kel (terminal rate constant) and AUC\_% Extrap\_Obs (residual area in percentage determined by formula) for ASA and pantoprazole in relevant treatments
| Arm | Type | Description |
|---|---|---|
| Overall Study Arm | EXPERIMENTAL | All the subjects in this study will take part in 3 treatment periods with one of the following treatments in each period. Subjects will receive all three treatments (one per period) in a random order in fed condition. Test 1= Fixed dose combination (FDC) formulation one of a capsule containing ASA 100 mg and pantoprazole 20 mg. Test 2= FDC formulation two of a capsule containing ASA 100 mg and pantoprazole 20 mg. Reference= ASA 100 mg tablet + pantoprazole 20 mg gastro-resistant tablet |
| Name | Type | Description |
|---|---|---|
| Test 1= ASA 100 mg and pantoprazole 20 mg capsule formulation one | DRUG | Formulation Test 1 of a fixed dose combination capsule of ASA and pantoprazole (Each capsule contains ASA 100 mg and pantoprazole 20 mg) manufactured by Piramal Healthcare Limited, India for GSK |
| Test 2= ASA 100 mg and pantoprazole 20 mg capsule formulation two | DRUG | Formulation Test 2 of a fixed dose combination capsule of ASA and pantoprazole (Each capsule contains ASA 100 mg and pantoprazole 20 mg) manufactured by Piramal Healthcare Limited, India for GSK |
| ASA 100 mg tablet | DRUG | Aspirin® Protect 100 mg tablets (Each tablet contains ASA 100 mg) manufactured by Bayer vital GmbH, 51368 Leverkusen, Germany |
| Pantoprazole 20 mg gastro-resistant tablet | DRUG | Protium® 20 mg gastro-resistant tablets (Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium sesquihydrate)) marketing authorisation holder Nycomed GmbH, Byk-Gulden-Straβe 2, D-78467, Konstanz, Germany |
Inclusion criteria: * Healthy human subjects within the age range of 18 to 45 years (both inclusive) * Non-smokers since at least six months * Willingness to provide written informed consent to participate in the study * Body-mass index (BMI) of \>=18.5 kilogram per meter square (kg/m\^2) and \<=24...
ASA is an investigational small molecule being developed for ulcers, specifically duodenal and gastric ulcers. It is a fixed-dose combination capsule containing acetylsalicylic acid 100 mg and pantoprazole 20 mg. The drug is currently in Phase 1 clinical development and is not yet approved.
ASA is being developed by GSK plc, which trades under the ticker GSK. The company is conducting Phase 1 clinical trials for this fixed-dose combination of acetylsalicylic acid and pantoprazole, intended for duodenal and gastric ulcers.
ASA is in Phase 1 clinical development. Two Phase 1 trials have been completed, each enrolling 24 healthy volunteers. The drug is investigational and has not been approved for any use.
ASA has two completed Phase 1 trials: NCT01847404, a comparative bioavailability study under fasting conditions, and NCT01847417, a similar study under fed conditions. Both trials enrolled 24 healthy volunteers in India and studied the fixed-dose combination of ASA 100 mg and pantoprazole 20 mg.
ASA is the abbreviation for acetylsalicylic acid, which is the active ingredient in the drug. The investigational product combines acetylsalicylic acid 100 mg with pantoprazole 20 mg in a single capsule, intended for duodenal and gastric ulcers.